four paqesl .................. 8- 10 Other Biographical Sketches (Not to exceed fourpages for each - See instructions)) ........................ 11 16 Resources .................................... ............................................................................................................. 17 Page Numbers 1 Research Plan 18 61 Introduction to Revised Application (Not to exceed 3 pages) ........................................................................................................... 18 2O Introduction to Supplemental Application (Not to exceed one page) ................................................................................................ 21 A. Specific Aims ........................................................................... ,_ ....................................................................................... 21 23 B. Background and Significance .................................................. ....|. ..................................................................................... |. 23 31 C. Preliminary Studies/Progress Report/ _ (Items A-D: not to exceed 25 pages*) ,._ Phase I Progress Repo_p_(SBtR/STTR Phase II ONLY) _ * SBIR/S TTR Phase h Items A-D limited to 15 pages, l D. Research Design and Methods',.=cent,............................................ _1 ........................................................................................ I 31 47 E. Human Subjects ..................................................................................................................................................................... NA Protection of Human Subjects (Required if Item 4 on the Face Page is marked =Yes") Inclusion of Women (Required if Item 4 on the Face Page is marked "Yes') .................................................................. Inclusion of Minorities (Required if Item 4 on the Face Page is marked "Yes") ................................................................ Inclusion of Children (Required if Item 4 on the Face Page is marked "Yes") .................................................................. Data and Safety Monitoring Plan (Required if Item 4 on the Face Page is marked "Yes" and a Phase I, II, or III clinical trial is proposed .......................................................................................................................................................... F. Vertebrate Animals ................................................................................................................................................................. 47 48 G. Literature Cited ....................................................................................................................................................................... 48 57 H. Consortium/Contractual Arrangements .................................................................................................................................. 57 I. Letters of Support (e.g., Consultants) .................................................................................................................................... 58 61 J. Product Development Plan (SBIPJSTTR Phase II and Fast-Track ONLY) ........................................................................... Checklist .................................................................................................................................................... 62 Check if Appendix (Five_e_sets. No page numbering necessary for Appendix.) Appendix is Included A_en_es NOT PERMITTED for Phase I SBIR/S TTR unless specifically solicited. Number of publications and manuscripts accepted for publication (not to exceed 10) 10 Other items (list): Abbreviations PHS 398 (Rev. 05/01 ) Page 3 Form Page 4